Comparative effectiveness and safety of inclisiran versus evolocumab and alirocumab: a 180-day real-world study.

BACKGROUND AND

OBJECTIVES

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have become an important therapeutic option for patients with dyslipidemia. Evolocumab and alirocumab are monoclonal antibodies targeting circulating PCSK9, whereas inclisiran is a small interfering RNA (siRNA) agent that suppresses hepatic PCSK9 synthesis and requires only twice-yearly dosing. Although these agents are proven effective in clinical trials, direct real-world comparative evidence on lipid-lowering efficacy, apolipoprotein B (apoB) reduction, safety, and adherence remains limited.

METHODS

This was a real-world, retrospective study conducted at a single center. A total of 198 patients were consecutively enrolled and assigned to three groups (n = 66 per group): inclisiran, evolocumab, or alirocumab. Baseline characteristics, including age, sex, and familial hypercholesterolemia (FH) status (assessed by DLCN criteria), were well-balanced across cohorts. All lipid parameters were analyzed using standardized automated biochemical analyzers at a centralized laboratory to ensure measurement consistency.

RESULTS

At 180 days, all three agents achieved robust and significant reductions in LDL-C from baseline (p < 0.001), with no significant differences observed between the groups. Notably, inclisiran demonstrated a numerical advantage in the reduction of apolipoprotein B (apoB) compared with evolocumab and alirocumab at 180 days (0.650 g/Lvs.0.774 g/L and 0.752 g/L, respectively), although these between-group differences did not reach formal statistical significance (p > 0.05). Treatment persistence was highest in the inclisiran group (69.7%), followed by evolocumab (56.1%) and alirocumab (50.0%). All therapies were well-tolerated with no new safety signals.

CONCLUSIONS

In this real-world study, Inclisiran, evolocumab, and alirocumab are all highly effective in lowering LDL-C in a real-world setting. Inclisiran may offer additional clinical value through superior treatment persistence and a favorable numerical trend toward enhanced apoB suppression.